Identity
- Trade Name
- EndoSerter EUDAMEDFDA UDI
- Generic Name
- Donor cornea delivery set FDA UDI
- Device Name
- EndoSerter EUDAMEDThe EndoSerter Corneal Endothelium Delivery Instrument is a device used for delivering a corneal endothelial allograft into the eye. The EndoSerter consists of the instrument’s body and its internal mechanism and carrier. The EndoSerter is a sterile, disposable, single-use only device. When loaded with allograft tissue, rotated, and inserted into the eye the allograft can be deployed in the anterior chamber. FDA UDI
- Model / Reference
- ES-1 EUDAMEDFDA UDI
- Description
- The EndoSerter Corneal Endothelium Delivery Instrument is a device used for delivering a corneal endothelial allograft into the eye. The EndoSerter consists of the instrument’s body and its internal mechanism and carrier. The EndoSerter is a sterile, disposable, single-use only device. When loaded with allograft tissue, rotated, and inserted into the eye the allograft can be deployed in the anterior chamber. FDA UDI
Identifiers
- Catalog Number
- ES-1 FDA UDI
- Primary DI / UDI-DI
- 00855934007003 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855934007003 EUDAMED
- FDA Product Code
- OTZ FDA UDI
- EMDN Code
- Q020299 CORNEA EXPLANTATION AND TRANSPLANTATION DEVICES - OTHER EUDAMED
- GMDN Term
- Donor cornea delivery set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4300 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EndoSerter by CorneaGen — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00855934007003 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CorneaGen
- EUDAMED SRN
- US-MF-000028846
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9a8417fd-b5b7-4675-aa3f-bc8c4eb8e9d6 61 fields · synced Jul 19, 2026
- FDA UDI 58642d14-7621-4826-b480-9d40ebd25704 34 fields · synced May 30, 2026